Clinical Trials /

Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

NCT01754519

Description:

This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.

Related Conditions:
  • Breast Carcinoma
  • Ductal Carcinoma In Situ
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
  • Official Title: Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: I 108907
  • SECONDARY ID: NCI-2009-01568
  • SECONDARY ID: I 108907
  • SECONDARY ID: P30CA016056
  • NCT ID: NCT01754519

Conditions

  • Ductal Breast Carcinoma In Situ
  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • Invasive Cribriform Breast Carcinoma
  • Invasive Ductal Carcinoma, Not Otherwise Specified
  • Lobular Breast Carcinoma In Situ
  • Mucinous Breast Carcinoma
  • Papillary Breast Carcinoma
  • Progesterone Receptor Positive
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIC Breast Cancer
  • Tubular Breast Carcinoma

Purpose

This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.

Detailed Description

      PRIMARY OBJECTIVE:

      I. For select patients with early stage breast cancer undergoing wide local excision followed
      by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated
      toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and
      quality of life as well as delivery of intended dose.

      SECONDARY OBJECTIVE:

      I. Locoregional control reported at five years.

      OUTLINE:

      Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once
      negative margins are obtained.

      After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and
      then every 6 months for 2 years.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (radiation therapy)ExperimentalPatients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing
                 invasive mammary cancer (with or without concomitant ductal carcinoma or lobular
                 carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of
                 invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and
                 "NOS" (not otherwise specified); invasive lobular cancer is excluded
    
              -  Age >= 50 years and postmenopausal with no menses for at least one year prior to study
                 enrollment
    
              -  Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years
                 with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and
                 postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5
                 cm (clinical tumor size will be determined by pre-operative breast
                 imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of
                 multiple measurements, the largest recorded single dimension will be used to determine
                 eligibility)
    
              -  Hormone receptor status
    
                   -  Estrogen or progesterone receptor positive or
    
                   -  Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cm
    
              -  Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy
                 analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in
                 situ hybridization analysis
    
              -  Tumor >= 0.5 cm from skin as defined by breast ultrasound
    
              -  Unicentric tumor
    
              -  Axillary lymph nodes negative by pre-operative physical examination in all cases and
                 pathologic examination from surgery for invasive disease
    
              -  Negative surgical margins, defined as no margin-labeling ink on tumor cells from
                 margin evaluation
    
            Exclusion Criteria:
    
              -  Initial core biopsy showing invasive lobular cancer
    
              -  Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm
    
              -  Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in
                 situ hybridization [FISH])
    
              -  Cancer in a patient with a known inherited susceptibility mutation in breast cancer
                 (BRCA)1 or BRCA2
    
              -  Multicentric breast cancer (two foci of known cancer in the breast separated by
                 greater than 5 cm, or in separate quadrants
    
              -  Clinically or pathologically positive axillary lymph nodes
    
              -  Any prior breast cancer
    
              -  Prior breast radiation therapy
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of Patients With Adverse Events as a Measure of Safety and Tolerability
    Time Frame:Up to 2 years
    Safety Issue:
    Description:Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.

    Secondary Outcome Measures

    Measure:Locoregional Control Rate
    Time Frame:At 5 years
    Safety Issue:
    Description:Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.
    Measure:Overall Survival
    Time Frame:Up to 5 years
    Safety Issue:
    Description:The overall survival will be analyzed using Kaplan-Meier method.
    Measure:Disease Specific Survival
    Time Frame:Up to 5 years
    Safety Issue:
    Description:The disease specific survival will be analyzed using Kaplan-Meier method.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Terminated
    Lead Sponsor:Roswell Park Cancer Institute

    Last Updated

    June 7, 2017